Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract: A Multicenter Pediatric Heart Network Scholar Study

Mary Hunt Martin; Jeffery Meadows; Doff B. McElhinney; Bryan H. Goldstein; Lisa Bergersen; Athar M. Qureshi; Shabana Shahanavaz; Jamil Aboulhosn; Darren Berman; Lynn Peng; Matthew Gillespie; Aimee Armstrong; Cindy Weng; L. LuAnn Minich; Robert G. Gray

doi:10.1016/j.jcin.2018.05.051

JACC: Cardiovascular Interventions

August 2018 DOI: 10.1016/j.jcin.2018.05.051

Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract
A Multicenter Pediatric Heart Network Scholar Study

Mary Hunt Martin, Jeffery Meadows, Doff B. McElhinney, Bryan H. Goldstein, Lisa Bergersen, Athar M. Qureshi, Shabana Shahanavaz, Jamil Aboulhosn, Darren Berman, Lynn Peng, Matthew Gillespie, Aimee Armstrong, Cindy Weng, L. LuAnn Minich and Robert G. Gray

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DOI:

https://doi.org/10.1016/j.jcin.2018.05.051

Published By:

JACC: Cardiovascular Interventions

Print ISSN:

1936-8798

Online ISSN:

1876-7605

History:

Received March 22, 2018
Revision received May 7, 2018
Accepted May 15, 2018
Published online August 1, 2018.

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2018 American College of Cardiology Foundation

Author Information

Mary Hunt Martin, MD^a,^∗ (mary.hunt.martin{at}hsc.utah.edu),
Jeffery Meadows, MD^b,
Doff B. McElhinney, MD^c,^d,
Bryan H. Goldstein, MD^e,
Lisa Bergersen, MD^f,
Athar M. Qureshi, MD^g,
Shabana Shahanavaz, MD^h,
Jamil Aboulhosn, MDⁱ,
Darren Berman, MD^j,
Lynn Peng, MD^c,
Matthew Gillespie, MD^k,
Aimee Armstrong, MD^l,
Cindy Weng, MS^m,
L. LuAnn Minich, MD^a and
Robert G. Gray, MD^a

^aDivision of Cardiology, Department of Pediatrics, University of Utah, Salt Lake City, Utah
^bDivision of Cardiology, Department of Pediatrics, University of California San Francisco, San Francisco, California
^cDivision of Cardiology, Department of Pediatrics, Lucile Packard Children’s Hospital at Stanford, Palo Alto, California
^dDepartment of Cardiothoracic Surgery, Lucile Packard Children’s Hospital at Stanford, Palo Alto, California
^eDivision of Cardiology, Department of Pediatrics, Cincinnati Children’s Hospital, Cincinnati, Ohio
^fDepartment of Cardiology, Boston Children’s Hospital, Boston, Massachusetts
^gThe Lillie Frank Abercrombie Section of Cardiology, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas
^hDivision of Cardiology, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri
ⁱDivision of Cardiology, Department of Pediatrics, University of California Los Angeles, Los Angeles, California
^jDivision of Cardiology, Department of Pediatrics, Nationwide Children’s Hospital, Columbus, Ohio
^kDivision of Cardiology, Department of Pediatrics, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
^lDivision of Cardiology, Department of Pediatrics, C.S. Mott Children’s Hospital, Ann Arbor, Michigan
^mDepartment of Statistics, University of Utah, Salt Lake City, Utah

↵∗Address for correspondence:
Dr. Mary Hunt Martin, University of Utah, Primary Children’s Hospital, 81 N. Mario Capecchi Drive, Salt Lake City, Utah 84113.

Graphical abstract

Abstract

Objectives This study sought to determine the safety and feasibility of transcatheter pulmonary valve replacement (TPVR) using the Melody valve in native (nonconduit) right ventricular outflow tracts (nRVOT), and to identify factors associated with successful TPVR.

Background The Melody valve is Food and Drug Administration–approved for TPVR within right ventricle-to-pulmonary artery conduits and bioprosthetic pulmonary valves. However, most patients needing pulmonary valve replacement have nRVOT and TPVR has been adapted for this indication.

Methods In this multicenter retrospective study of all patients presenting for nRVOT TPVR, we collected pre-procedural magnetic resonance imaging, echocardiography, and catheterization data, and evaluated procedural and early outcomes.

Results Of 229 patients (age 21 ± 15 years from 11 centers), 132 (58%) had successful TPVR. In the remaining 97, TPVR was not performed, most often because of prohibitively large nRVOT (n = 67) or compression of the aortic root or coronary arteries (n = 18). There were no deaths and 5 (4%) serious complications, including pre-stent embolization requiring surgery in 4 patients, and arrhythmia in 1. Higher pre-catheterization echocardiographic RVOT gradient was associated with TPVR success (p = 0.001) and larger center volume approached significance (p = 0.08). Magnetic resonance imaging anterior-posterior and lateral RVOT diameters were smaller in implanted versus nonimplanted patients (18.0 ± 3.6 mm vs. 20.1 ± 3.5 mm; p = 0.005; 18.4 ± 4.3 mm vs. 21.5 ± 3.8 mm; p = 0.002).

Conclusions TPVR in the nRVOT was feasible and safe. However, nearly half the patients presenting for catheterization did not undergo TPV implantation, mainly because of prohibitively large nRVOT size. Improved understanding of magnetic resonance imaging data and availability of larger devices may improve the success rate for nRVOT TPVR.

Key Words

Footnotes

Funded by the National Heart Lung Blood Institute Pediatric Heart Network Scholar Award, Bethesda, Maryland. Dr. McElhinney is a proctor for Medtronic. Dr. Goldstein is a proctor for Edwards Lifesciences and a consultant for Medtronic. Dr. Bergersen is a consultant for 480 Biomedical Inc. Dr. Shahanavaz is a proctor for Edwards Lifesciences and a consultant for Medtronic. Dr. Aboulhosn is a co-PI at UCLA for the Medtronic Harmony valve trial. Dr. Berman is a proctor for Edwards Lifesciences. Dr. Gillespie is a consultant and proctor for Medtronic. Dr. Armstrong is a proctor/consultant for Abbott, B. Braun Interventional Systems Inc., and Edwards Lifesciences; and has received research grants from Abbott, Edwards Lifesciences, Medtronic, and Siemens Medical Solutions USA Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Received March 22, 2018.
Revision received May 7, 2018.
Accepted May 15, 2018.

2018 American College of Cardiology Foundation

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